# K170958: ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm

- Pathway: 510(k) (Traditional)
- Applicant: Tricol Biomedical, Inc.
- Decided: Aug 29, 2017 after 151 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K984177 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151363: Zephyr Vascular Compression Device, Advanced Vascular Dynamics (2015) Summary page 4.
- K142359: Vasc Band hemostat, Lepu Medical Technology (Beijing) Co., Ltd. (2014) Summary page 4.

## Indications for use
ChitoPulse™ Radial Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient’s radial artery, including arterial or venous line or sheath removal, hemodialysis and in patients on anticoagulation therapy. ChitoPulse™ Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient’s leg, including dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal and in patients on anticoagulation therapy.

Source page: https://510kreport.com/device/K170958
Methodology: https://510kreport.com/methodology